NUMBRINO

Product NDC
81665-300
11-digit product format
816650300
Labeler code
81665
Product ID
81665-300_b722df62-ac8d-49c0-b357-c814b89471fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cocaine hydrochloride nasal
Dosage form
SOLUTION
Route
TOPICAL
Labeler
OMNIVIUM PHARMACEUTICALS LLC.
Application
NDA209575
Marketing category
NDA
Marketing start
2024-06-19
Substance
COCAINE HYDROCHLORIDE
Active strength
40 mg/mL
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209575-001NUMBRINOCOCAINE HYDROCHLORIDE4%SOLUTION / NASALRLD, RS2020-01-10

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209575-001100164072037-02-07U-22252023-08-28
N209575-001100164072037-02-07U-22262023-08-28
N209575-001100164072037-02-07U-23292023-08-28
N209575-001101498432037-02-07U-24782023-08-28
N209575-001101498432037-02-07U-24792023-08-28
N209575-001102319612037-02-07Drug product2023-08-28
N209575-001104135052037-02-07U-30142023-08-28
N209575-001104207602037-02-07U-24782023-08-28
N209575-001108570952037-02-07U-30142023-08-28
N209575-001108940122037-02-07U-30142023-08-28
N209575-001109330602037-02-07U-24782023-08-28
N209575-001109330602037-02-07U-30142023-08-28
N209575-001109738112037-02-07U-36802023-08-28
N209575-001110400322037-02-07Drug product2023-08-28
N209575-00198678152037-02-07U-22252023-08-28
N209575-00198678152037-02-07U-22262023-08-28
N209575-00198678152037-02-07U-22272023-08-28
N209575-00198678152037-02-07U-23292023-08-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-104b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209575-001NUMBRINO4%SOLUTION / NASAL2020-01-10c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209575-001100164072037-02-07U-22252023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001100164072037-02-07U-22262023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001100164072037-02-07U-23292023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001101498432037-02-07U-24782023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001101498432037-02-07U-24792023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001102319612037-02-07Drug product2023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001104135052037-02-07U-30142023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001104207602037-02-07U-24782023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001108570952037-02-07U-30142023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001108940122037-02-07U-30142023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001109330602037-02-07U-24782023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001109330602037-02-07U-30142023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001109738112037-02-07U-36802023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001110400322037-02-07Drug product2023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-00198678152037-02-07U-22252023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-00198678152037-02-07U-23292023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-00198678152037-02-07U-22272023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-00198678152037-02-07U-22262023-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209575-001100164072037-02-07U-22252023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001100164072037-02-07U-22262023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001100164072037-02-07U-23292023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001101498432037-02-07U-24782023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001101498432037-02-07U-24792023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001102319612037-02-07Drug product2023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001104135052037-02-07U-30142023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001104207602037-02-07U-24782023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001108570952037-02-07U-30142023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001108940122037-02-07U-30142023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001109330602037-02-07U-24782023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001109330602037-02-07U-30142023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001109738112037-02-07U-36802023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001110400322037-02-07Drug product2023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-00198678152037-02-07U-22252023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-00198678152037-02-07U-23292023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-00198678152037-02-07U-22272023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-00198678152037-02-07U-22262023-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001100164072037-02-07U-22252023-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001100164072037-02-07U-22262023-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001100164072037-02-07U-23292023-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001101498432037-02-07U-24782023-08-2831067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209575-001NCE2022-12-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209575-001NP2023-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209575-001NCE2022-12-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209575-001NP2023-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209575-001NCE2022-12-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209575-001NP2023-01-104b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N209575-001NCE2022-12-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209575-001NP2023-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209575-001NCE2022-12-14782e0a99824c…
2021-12-28 21:50 UTC2021-12N209575-001NP2023-01-10782e0a99824c…
2023-12-20 04:57 UTC2023-12N209575-001NP2023-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209575-001NP2023-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209575-001NP2023-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209575-001NP2023-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209575-001NP2023-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N209575-001NP2023-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N209575-001NCE2022-12-143bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N209575-001NP2023-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209575-001NCE2022-12-143a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209575-001NP2023-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209575-001NCE2022-12-14f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N209575-001NP2023-01-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209575-001NCE2022-12-14e64feba35796…
2022-09-29 23:25 UTC2022-09N209575-001NP2023-01-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209575-001NCE2022-12-14cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209575-001NP2023-01-10cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
NUMBRINO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCAINE HYDROCHLORIDE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XH8T8T6WZHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1995288Internal RxNorm lookup
2272608Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d724b5b4-6654-4bf5-9eed-e2c7943084edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc803e48-5aa8-4a87-8ab4-fcff7feb5dd5Product name120200610
8e5656e6-cd09-45b0-8d65-fbeaa5f1dc4eProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81665-300-02NUMBRINO1 in 1 CARTONSOLUTION13
81665-300-02NUMBRINO4 mL in 1 BOTTLE, GLASSSOLUTION43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81665-300-02ML - Milliliter81665-300611db05a-e72e-4a2c-a625-dfaca082730512024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81665-300NUMBRINO (COCAINE HYDROCHLORIDE NASAL) SOLUTION [OMNIVIUM PHARMACEUTICALS LLC.]2Current NDC, 2 package rows20240622_d724b5b4-6654-4bf5-9eed-e2c7943084ed.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUMBRINOCOCAINE HYDROCHLORIDE NASALOMNIVIUM PHARMACEUTICALS LLC.d724b5b4-6654-4bf5-9eed-e2c7943084ed2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209575
application number: NDA209575
ndc (product): 81665-300
cocaine hydrochloride nasalCOCAINE HYDROCHLORIDE NASALOMNIVIUM PHARMACEUTICALS LLC.4e3b2f6b-1b57-40bc-872b-01c0a3c7986e2023-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209575
application number: NDA209575

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995288cocaine hydrochloride 4 % Nasal SolutionPSNd724b5b4-6654-4bf5-9eed-e2c7943084ed3
2272608NUMBRINO 4 % (40 MG/ML) Nasal SolutionPSNd724b5b4-6654-4bf5-9eed-e2c7943084ed3
2272608cocaine hydrochloride 40 MG/ML Nasal Solution [Numbrino]SBDd724b5b4-6654-4bf5-9eed-e2c7943084ed3
1995288cocaine hydrochloride 40 MG/ML Nasal SolutionSCDd724b5b4-6654-4bf5-9eed-e2c7943084ed3
1995288cocaine hydrochloride 4 % Nasal SolutionSYd724b5b4-6654-4bf5-9eed-e2c7943084ed3
2272608Numbrino 40 MG/ML Nasal SolutionSYd724b5b4-6654-4bf5-9eed-e2c7943084ed3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81665-300-02816650300021 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS2024-06-19NoNoCurrent